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The Carevature DReal™ is intended to be used with high-speed compatible electric and pneumatic motors. When used with these motors, it is intended to cut bone by drilling, reaming, decorticating, shaping, dissecting, shaving and smoothing for neurosurgical and spinal applications. Specific applications include laminectomy/laminotomy and craniotomy/craniectomy/ skull base cuts

The DReal™ is a handheld bone-removal device based on a rotating cutter, with a protective shield (hood) partially covering the cutter; following its indications for use, it is designed to cut bone

The device in question is the DReal™, a handheld bone-removal device. The provided document is a 510(k) Pre-market Notification for the DReal™, demonstrating its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary indicates that for each performance test, the device "passed the test" and "The acceptance criteria were met." However, specific quantitative acceptance criteria values are generally not detailed in this type of summary. The table below lists the performance tests and the reported results:

2. Sample Size Used for the Test Set and Data Provenance

• Biocompatibility Testing: The sample sizes are specific to the biological tests performed (e.g., rabbits for irritation, guinea pigs for sensitization, mice for systemic toxicity). Specific numerical sample sizes beyond the general animal models are not explicitly stated in this summary.
• Sterilization, Packaging, and Shelf Life Testing: Sample sizes are not specified, but the tests were performed on device samples.
• Performance Testing:
  • Animal Feasibility Test: One live adult (7 months) pig.
  • Cadaver Feasibility Test: One skeletally mature human cadaver.
  • For other performance tests (simulated use, temperature, slippage, chatter, fatigue, motor compatibility, excessive vibration), the sample size of devices tested is not specified in this summary.
• Data Provenance: Not explicitly stated, but given the manufacturer is Carevature Medical Ltd. in Israel, it is likely that the testing (especially feasibility tests) was conducted there or arranged through a contract research organization. The studies are assumed to be prospective as part of the premarket notification process for the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information (number and qualifications of experts for ground truth) is not typically required or provided in a 510(k) summary for mechanical surgical devices. The "ground truth" for these tests primarily relies on objective measurements against established engineering and biological standards (e.g., ISO, ASTM, USP standards) and direct observation by qualified technicians and researchers conducting the tests.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish a "ground truth" for diagnostic or AI-based devices. For this mechanical surgical device, the "adjudication" is inherent in passing or failing objective engineering and biocompatibility tests against predefined standards. There is no mention of a separate expert adjudication process for these tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. These studies are relevant for diagnostic devices where human readers interpret images, and the AI's assistance to human readers is evaluated. The DReal™ is a surgical tool, not a diagnostic imaging AI.

6. If a Standalone Performance (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable. The DReal™ is a mechanical surgical device operated by a surgeon, not an algorithm. Its performance is evaluated through its physical properties, safety, and functionality, not as a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth for this device is based on several objective measures and established standards:

• Biocompatibility: In vitro and in vivo testing against ISO and USP standards.
• Sterilization, Packaging, and Shelf Life: Validation against ISO standards.
• Performance Testing (Simulated Use, Temperature, Fatigue, etc.): Objective measurements of mechanical properties, material removal efficacy, temperature generation, durability, and compatibility against predefined engineering specifications and regulatory standards (e.g., ASTM).
• Feasibility Tests (Animal and Cadaver): Direct observation of safety, performance, and gross bone volume reduction in a controlled environment.

8. The Sample Size for the Training Set

This question is not applicable. The DReal™ is a mechanical device, not an AI or machine learning algorithm that requires a training set. Its design and manufacturing are based on engineering principles and materials science.

9. How the Ground Truth for the Training Set was Established

This question is not applicable as there is no training set for this mechanical surgical device.

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